This is an observational, prospective/retrospective multicentre, cohort study of children diagnosed with cCMV. This study will contribute to a wider study also recruiting participants in Europe and other countries worldwide. No investigations or treatment will be carried out that are not part of routine clinical practice. Infants with cCMV are routinely followed up from an infectious diseases, audiology, ophthalmology and neurodevelopmental perspective until approximately 6 years of age, or longer if there are ongoing issues. Some children will be retrospectively diagnosed with cCMV in later childhood. Recruitment can be from any centre that manages these patients and has agreed to participate in the study.
Cytomegalovirus (CMV) is the most frequent cause of congenital infection worldwide, occurring in 0.2-2% of live births. It is also the most frequent cause of non-genetic hearing loss, and an important cause of neurodevelopmental delay. Clinical diagnosis of maternal infection during pregnancy is unreliable in most patients and laboratory diagnosis can be challenging, especially in non-primary infections. Screening of congenital CMV infection (cCMV) in newborns is not recommended in most countries and only targeted screening is performed in some cases (children who fail hearing screening or with abnormalities compatible with cCMV in physical exams). The main focus of the study is to identify patient and treatment characteristics that are associated with outcome. This will allow improved patient care in the future.
Study Type
OBSERVATIONAL
Enrollment
200
St George's University of London
London, United Kingdom
RECRUITINGMeasuring cases of cCMV in the UK
To analyze the epidemiology of children born with cCMV
Time frame: 15 years
Clinical characteristics
To analyze the clinical characteristic of children born with cCMV (measure is number of participants with hearing loss, retinitis, neurological abnormalities, skin rashes, or hepatosplenomegaly)
Time frame: 15 years
To evaluate risk factors in children with cCMV for long term sequelae
To measure the number of cases with abnormal brain imaging (cranial USS or MRI), hearing loss, retinitis or anaemia, leucopenia, thrombocytopenia, renal function or liver abnormalities at diagnosis
Time frame: 15 years
Adverse events
To document adverse events of different treatment strategies
Time frame: 15 years
To evaluate the prognostic value of microbiological variables
To measure the urine CMV viral load in cases at diagnosis who develop hearing loss
Time frame: 15 years
To evaluate the prognostic value of image findings
To measure the number of cases who have abnormal brain imaging (cranial USS or MRI) at diagnosis and develop hearing loss
Time frame: 15 years
To evaluate associated outcomes with different treatment strategies
To measure the number of cases treated with valganciclovir and the number of treated cases who need a treatment break
Time frame: 15 years
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